Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of 2026-10-22, the FDA export date. FDA medical device recall database

59,544 records, page 602 of 1191

FDA device recalls, page 602 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0759-2016	Class II	Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars...	Hill-Rom Inc.	JEA	2016-01-19
Z-2558-2019	Class II	V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic...	VitalScientific	JJF	2016-01-18
Z-1349-2016	Class II	A Picture Archiving and Communication System (PACS) intended to display, process, read...	Siemens Medical Solutions USA, Inc.	LLZ	2016-01-18
Z-1084-2016	Class II	Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a...	Sedecal S.A.	IZL	2016-01-18
Z-1065-2016	Class II	Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin...	Respironics, Inc.	CBK	2016-01-18
Z-0816-2016	Class II	LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6...	Smith & Nephew, Inc.	JWH	2016-01-18
Z-0815-2016	Class III	CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description...	Lab Vision Corp.	NJT	2016-01-18
Z-0887-2016	Class II	Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use...	Fresenius Medical Care Renal Therapies Group, LLC	KPO	2016-01-18
Z-1509-2016	Class III	OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming...	OraSure Technologies, Inc.	MZO	2016-01-15
Z-1994-2016	Class II	Universal Battery Charger II (UBC II)	The Anspach Effort, Inc.	MOQ	2016-01-15
Z-1031-2016	Class II	Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or...	Mako Surgical Corp.	NPJ	2016-01-15
Z-0758-2016	Class II	2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System...	Spectranetics Corp.	MCW	2016-01-15
Z-0814-2016	Class II	Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An...	CareFusion 303, Inc	BRY	2016-01-15
Z-1181-2016	Class II	Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to...	Medtronic, Inc.	CBK	2016-01-15
Z-0825-2016	Class II	BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro...	Siemens Healthcare Diagnostics Inc.	JPA	2016-01-14
Z-0824-2016	Class II	BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro...	Siemens Healthcare Diagnostics Inc.	JPA	2016-01-14
Z-1175-2016	Class II	Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000 is intended for use...	Canon Medical Systems USA, Inc.	JAA	2016-01-14
Z-0829-2016	Class II	9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E...	ZOLL Medical Corporation	MKJ	2016-01-14
Z-0803-2016	Class II	Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is...	Evident Scientific MIS, Inc.	RBY	2016-01-13
Z-1266-2016	Class II	The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)	SterCUBE Surgical Systems, LLC	KCT	2016-01-13
Z-1067-2016	Class II	iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079...	Siemens Healthcare Diagnostics Inc.	KQO	2016-01-13
Z-1243-2016	Class II	IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26...	Siemens Healthcare Diagnostics Inc.	CHP	2016-01-13
Z-1242-2016	Class II	IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN...	Siemens Healthcare Diagnostics Inc.	CHP	2016-01-13
Z-1241-2016	Class II	Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product...	Siemens Healthcare Diagnostics Inc.	CHP	2016-01-13
Z-1240-2016	Class II	Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445...	Siemens Healthcare Diagnostics Inc.	CHP	2016-01-13
Z-0746-2016	Class II	Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as...	ResMed Corp	CBK	2016-01-13
Z-1064-2016	Class II	Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DYB	2016-01-12
Z-1360-2016	Class II	Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a...	Arthrex GmbH	HRS	2016-01-11
Z-1499-2016	Class II	Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It...	Leica Microsystems, Inc.	FSO	2016-01-11
Z-1170-2016	Class II	Product 72 consists of all product code: JDI and same usage: Item no: 805002202 ZIMTRON...	Zimmer Manufacturing B.V.	JDI	2016-01-11
Z-1169-2016	Class II	Product 71 consists of all product under product code: JDI and same usage: Item...	Zimmer Manufacturing B.V.	JDI	2016-01-11
Z-1168-2016	Class II	Product 70 consists of all product under product code: JDI and same usage: Item...	Zimmer Manufacturing B.V.	JDI	2016-01-11
Z-1167-2016	Class II	Product 69 consists of all product under product code: JDI and same usage: Item...	Zimmer Manufacturing B.V.	JDI	2016-01-11
Z-1166-2016	Class II	Product 68 consists of all product under product code: JDI and same usage: Item...	Zimmer Manufacturing B.V.	JDI	2016-01-11
Z-1165-2016	Class II	Product 67 consists of all product under product code: JDI and same usage: Item...	Zimmer Manufacturing B.V.	JDI	2016-01-11
Z-1164-2016	Class II	Product 66 consists of all product under product code: JDI and same usage: Item...	Zimmer Manufacturing B.V.	JDI	2016-01-11
Z-1163-2016	Class II	Product 65 consists of all product under product code: KTT and same usage: Item...	Zimmer Manufacturing B.V.	KTT	2016-01-11
Z-1162-2016	Class II	Product 64 consists of all product under product code: JDI and same usage: Item...	Zimmer Manufacturing B.V.	JDI	2016-01-11
Z-1161-2016	Class II	Product 63 consists of all product under product code: LPH and same usage: Item...	Zimmer Manufacturing B.V.	LPH	2016-01-11
Z-1160-2016	Class II	Product 62 consists of all product under product code: LPH and same usage: Item...	Zimmer Manufacturing B.V.	LPH	2016-01-11
Z-1159-2016	Class II	Product 61 consists of all product under product code: JWH and same usage: Item...	Zimmer Manufacturing B.V.	JWH	2016-01-11
Z-1158-2016	Class II	Product 60 consists of all product under product code: HSB and same usage: Item...	Zimmer Manufacturing B.V.	HSB	2016-01-11
Z-1157-2016	Class II	Product 59 consists of all product under product code: JWH and same usage: Item...	Zimmer Manufacturing B.V.	JWH	2016-01-11
Z-1156-2016	Class II	Product 58 consists of all product under product code: HRS and same usage: Item...	Zimmer Manufacturing B.V.	HRS	2016-01-11
Z-1155-2016	Class II	Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT...	Zimmer Manufacturing B.V.	JDI	2016-01-11
Z-1154-2016	Class II	Product 56 consists of all product under product code: HWC and same usage: Item...	Zimmer Manufacturing B.V.	HWC	2016-01-11
Z-1153-2016	Class II	Product 55 consists of all product under product code: HSB and same usage: Item...	Zimmer Manufacturing B.V.	HSB	2016-01-11
Z-1152-2016	Class II	Product 54 consists of all product under product code: JWH and same usage: Item...	Zimmer Manufacturing B.V.	JWH	2016-01-11
Z-1151-2016	Class II	Product 53 consists of all product under: product code: JWH and same usage: Item...	Zimmer Manufacturing B.V.	JWH	2016-01-11
Z-1150-2016	Class II	Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN...	Zimmer Manufacturing B.V.	HWC	2016-01-11